To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
Not Applicable
- Conditions
- Nasolabial FOLD
- Interventions
- Device: HARA Filler(Hyaluronic acid Filler)Device: Restylane® Lidocaine
- Registration Number
- NCT04224649
- Lead Sponsor
- Huons Co., Ltd.
- Brief Summary
* Investigational Device : HARA (Hyaluronic Acid Filler)
* Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
* Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
* Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 67
Inclusion Criteria
- Those who agreed to this treatment and signed the Informed Consent Form
- Those who are 19 years old or more and desire to take correction of nasolabial folds
- Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Exclusion Criteria
- Those who are sensitive to lidocaine or other amide anesthesia
- Those who are sensitive to control device
- Those who are pregnant or lactating, or expect pregnancy
- Those who are judged by the subinvestigator to be improper for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Device Group(HARA filler) HARA Filler(Hyaluronic acid Filler) - Comparator Group(Restylane® Lidocaine) Restylane® Lidocaine -
- Primary Outcome Measures
Name Time Method Assessment By independent evaluator Week 24 From baseline Visit(=Investigational Device Injection) Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale)
\* Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huons
🇰🇷Seongnam-si, Korea, Republic of